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SAFETY DATA SHEET

C.f.a.s. HbA1c
Version Revision Date: Date of last issue: 06-15-2018
1.5 08-02-2018 Date of first issue: 11-20-2015

SECTION 1. IDENTIFICATION

Product name : C.f.a.s. HbA1c

Product code : 04528417190

Manufacturer or supplier's details


Company name of supplier : Roche Diagnostics
-

Address : 9115 Hague Road


46250 Indianapolis IN
USA

Telephone : 1-800-428-5074
Emergency telephone
In case of emergencies: : CHEMTREC 1-800-424-9300 (U.S. or Ca-
nada)
1-703-527-3887 (Internatio-
nal)
Recommended use of the chemical and restrictions on use
Restrictions on use : For professional users only.

SECTION 2. HAZARDS IDENTIFICATION

GHS classification in accordance with 29 CFR 1910.1200


The product is a kit consisting of individual ingredients. The classification of the ingredients can
be obtained from section 3. Section Label elements contains the resulting labelling for the kit
GHS label elements
Hazard pictograms :

Signal Word : Danger

Hazard Statements : H317 May cause an allergic skin reaction.


H318 Causes serious eye damage.
H334 May cause allergy or asthma symptoms or breathing diffi-
culties if inhaled.
H373 May cause damage to organs through prolonged or re-
peated exposure if swallowed.

Precautionary Statements :
Prevention:
P260 Do not breathe dust/ fume/ gas/ mist/ vapors/ spray.
P272 Contaminated work clothing must not be allowed out of
the workplace.
P280 Wear protective gloves/ eye protection/ face protection.
P285 In case of inadequate ventilation wear respiratory protec-
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SAFETY DATA SHEET

C.f.a.s. HbA1c
Version Revision Date: Date of last issue: 06-15-2018
1.5 08-02-2018 Date of first issue: 11-20-2015

tion.
Response:
P302 + P352 IF ON SKIN: Wash with plenty of soap and water.
P304 + P341 IF INHALED: If breathing is difficult, remove per-
son to fresh air and keep comfortable for breathing.
P305 + P351 + P338 + P310 IF IN EYES: Rinse cautiously with
water for several minutes. Remove contact lenses, if present
and easy to do. Continue rinsing. Immediately call a POISON
CENTER/doctor.
P333 + P313 If skin irritation or rash occurs: Get medical advice/
attention.
P342 + P311 If experiencing respiratory symptoms: Call a
POISON CENTER/doctor.
P363 Wash contaminated clothing before reuse.
Disposal:
P501 Dispose of contents/ container to an approved waste dis-
posal plant.

Other hazards
None known.

SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS

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GHS Classification
Serious eye damage : Category 1

Respiratory sensitization : Category 1

Skin sensitization : Category 1

Specific target organ systemic : Category 2


toxicity - repeated exposure
(Oral)

Hazardous ingredients
Chemical name CAS-No. Concentration (% w/w)
.alpha.-D-Glucopyranoside, .beta.-D- 57-50-1 >= 50 - < 70
fructofuranosyl
1-Tetradecanaminium, N,N,N-trimethyl-, 1119-97-7 >= 5 - < 10
bromide (1:1)
Edetic acid disodium salt dihydrate (EDTA- 6381-92-6 >= 5 - < 10
2Na-2H2O)
Poly(oxy-1,2-ethanediyl), .alpha.-dodecyl- 9002-92-0 >= 1 - < 3
.omega.-hydroxy-
3(2H)-Isothiazolone, 2-methyl-, hydrochlori- 26172-54-3 >= 0.1 - < 1
de (1:1)

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SAFETY DATA SHEET

C.f.a.s. HbA1c
Version Revision Date: Date of last issue: 06-15-2018
1.5 08-02-2018 Date of first issue: 11-20-2015

SECTION 4. FIRST AID MEASURES

General advice : Move out of dangerous area.


Consult a physician.
Show this material safety data sheet to the doctor in atten-
dance.
Do not leave the victim unattended.

If inhaled : Call a physician or poison control center immediately.


Move to fresh air.
If unconscious, place in recovery position and seek medical
advice.

In case of skin contact : If skin irritation persists, call a physician.


If on skin, rinse well with water.
If on clothes, remove clothes.

In case of eye contact : Small amounts splashed into eyes can cause irreversible tis-
sue damage and blindness.
In the case of contact with eyes, rinse immediately with plenty
of water and seek medical advice.
Continue rinsing eyes during transport to hospital.
Remove contact lenses.
Protect unharmed eye.
Keep eye wide open while rinsing.
If eye irritation persists, consult a specialist.

If swallowed : Keep respiratory tract clear.


Do NOT induce vomiting.
Do not give milk or alcoholic beverages.
Never give anything by mouth to an unconscious person.
If symptoms persist, call a physician.
Take victim immediately to hospital.
Rinse mouth with water.

Most important symptoms : No information available.


and effects, both acute and
delayed

Notes to physician : The first aid procedure should be established in consultation


with the doctor responsible for industrial medicine.

SECTION 5. FIRE-FIGHTING MEASURES

Suitable extinguishing media : Use extinguishing measures that are appropriate to local cir-
cumstances and the surrounding environment.

Unsuitable extinguishing : High volume water jet


media

Specific hazards during fire : Do not allow run-off from fire fighting to enter drains or water
fighting courses.

Further information : Collect contaminated fire extinguishing water separately. This


must not be discharged into drains.

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SAFETY DATA SHEET

C.f.a.s. HbA1c
Version Revision Date: Date of last issue: 06-15-2018
1.5 08-02-2018 Date of first issue: 11-20-2015

Fire residues and contaminated fire extinguishing water must


be disposed of in accordance with local regulations.

Special protective equipment : Wear self-contained breathing apparatus for firefighting if


for fire-fighters necessary.

SECTION 6. ACCIDENTAL RELEASE MEASURES

Personal precautions, protec- : Use personal protective equipment.


tive equipment and emer- Avoid dust formation.
gency procedures Avoid breathing dust.
Ensure adequate ventilation.

Environmental precautions : Prevent product from entering drains.


Prevent further leakage or spillage if safe to do so.
If the product contaminates rivers and lakes or drains inform
respective authorities.

Methods and materials for : Keep in suitable, closed containers for disposal.
containment and cleaning up

SECTION 7. HANDLING AND STORAGE

Advice on protection against : Avoid dust formation.


fire and explosion Provide appropriate exhaust ventilation at places where dust
is formed.

Advice on safe handling : Avoid formation of respirable particles.


Do not breathe vapors/dust.
Avoid exposure - obtain special instructions before use.
Avoid contact with skin and eyes.
For personal protection see section 8.
Smoking, eating and drinking should be prohibited in the ap-
plication area.
Provide sufficient air exchange and/or exhaust in work rooms.
Dispose of rinse water in accordance with local and national
regulations.
Persons susceptible to skin sensitization problems or asthma,
allergies, chronic or recurrent respiratory disease should not
be employed in any process in which this mixture is being
used.

Conditions for safe storage : Keep container tightly closed in a dry and well-ventilated pla-
ce.
Containers which are opened must be carefully resealed and
kept upright to prevent leakage.
Electrical installations / working materials must comply with
the technological safety standards.

Technical : See label, package insert or internal guidelines


measures/Precautions

Further information on stor- : No decomposition if stored and applied as directed.


age stability
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SAFETY DATA SHEET

C.f.a.s. HbA1c
Version Revision Date: Date of last issue: 06-15-2018
1.5 08-02-2018 Date of first issue: 11-20-2015

SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION

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Ingredients with workplace control parameters
Ingredients CAS-No. Value type Control parame- Basis
(Form of ters / Permissible
exposure) concentration
.alpha.-D- 57-50-1 TWA 10 mg/m3 ACGIH
Glucopyranoside, .beta.-D-
fructofuranosyl
TWA (Res- 5 mg/m3 NIOSH REL
pirable)
TWA (total) 10 mg/m3 NIOSH REL
TWA (total 15 mg/m3 OSHA Z-1
dust)
TWA (respir- 5 mg/m3 OSHA Z-1
able fraction)
TWA (Total 15 mg/m3 OSHA P0
dust)
TWA (respir- 5 mg/m3 OSHA P0
able dust
fraction)

Engineering measures : No data available

Personal protective equipment


Respiratory protection : In the case of dust or aerosol formation use respirator with an
approved filter.
Effective dust mask

Hand protection

Material : Protective gloves

Remarks : Wear appropriate protective gloves to prevent skin contact.


Replace torn or punctured gloves promptly.
Eye protection : Eye wash bottle with pure water
Tightly fitting safety goggles
Wear face-shield and protective suit for abnormal processing
problems.

Skin and body protection : Choose body protection according to the amount and con-
centration of the dangerous substance at the work place.

Hygiene measures : When using do not eat or drink.


When using do not smoke.
Wash hands before breaks and at the end of workday.

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SAFETY DATA SHEET

C.f.a.s. HbA1c
Version Revision Date: Date of last issue: 06-15-2018
1.5 08-02-2018 Date of first issue: 11-20-2015

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES

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Appearance : solid

Color : red brown

Odor : none

Odor Threshold : Not applicable

pH : Not applicable

Melting point/range : No data available

Boiling point/boiling range : No data available

Flash point : does not flash

Evaporation rate : No data available

Self-ignition : No data available

Upper explosion limit / Upper : No data available


flammability limit

Lower explosion limit / Lower : No data available


flammability limit

Vapor pressure : No data available

Relative vapor density : Not applicable

Relative density : No data available

Solubility(ies)
Water solubility : completely soluble

Solubility in other solvents : No data available

Partition coefficient: n- : No data available


octanol/water

Autoignition temperature : No data available

Decomposition temperature : No data available

Viscosity
Viscosity, dynamic : Not applicable

Viscosity, kinematic : Not applicable

Oxidizing properties : The substance or mixture is not classified as oxidizing.

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SAFETY DATA SHEET

C.f.a.s. HbA1c
Version Revision Date: Date of last issue: 06-15-2018
1.5 08-02-2018 Date of first issue: 11-20-2015

SECTION 10. STABILITY AND REACTIVITY

Reactivity : No dangerous reaction known under conditions of normal use.

Chemical stability : Stable under normal conditions.

Possibility of hazardous reac- : No dangerous reaction known under conditions of normal use.
tions No decomposition if stored and applied as directed.

Conditions to avoid : No data available

Incompatible materials : No data available

Hazardous decomposition : No data available


products

SECTION 11. TOXICOLOGICAL INFORMATION

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Acute toxicity
Not classified based on available information.
Ingredients:

.alpha.-D-Glucopyranoside, .beta.-D-fructofuranosyl:
Acute oral toxicity : LD50 Oral (Rat): 29,700 mg/kg

LD50 Oral (Mouse): 14,000 mg/kg

Acute inhalation toxicity : Acute toxicity estimate: > 30 mg/l


Test atmosphere: dust/mist
Method: Expert judgment

Acute dermal toxicity : Acute toxicity estimate: > 5,001 mg/kg


Method: Expert judgment

1-Tetradecanaminium, N,N,N-trimethyl-, bromide (1:1):


Acute oral toxicity : LD50 Oral (Rat): 333 - 460 mg/kg

Acute inhalation toxicity : LC50 (Mouse): 1,8 mg/m3


Test atmosphere: dust/mist

Acute dermal toxicity : LD50 Dermal (Rabbit): ca. 2,150 mg/kg

Edetic acid disodium salt dihydrate (EDTA-2Na-2H2O):


Acute oral toxicity : LD50 Oral (Rat): > 2,000 mg/kg
Test substance: anhydrous substance

LD50 Oral (Rabbit): 2,300 mg/kg

Acute inhalation toxicity : LC50 (Rat): 1 - 5 mg/l

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SAFETY DATA SHEET

C.f.a.s. HbA1c
Version Revision Date: Date of last issue: 06-15-2018
1.5 08-02-2018 Date of first issue: 11-20-2015

Exposure time: 6 h
Test atmosphere: dust/mist
Method: OECD Test Guideline 403
Test substance: anhydrous substance

Acute toxicity estimate: 1.5 mg/l


Test atmosphere: dust/mist
Method: Expert judgment

Poly(oxy-1,2-ethanediyl), .alpha.-dodecyl-.omega.-hydroxy-:
Acute oral toxicity : LD50 Oral (Rat): 1,000 mg/kg

Skin corrosion/irritation
Not classified based on available information.
Ingredients:

1-Tetradecanaminium, N,N,N-trimethyl-, bromide (1:1):


Result : Irritating to skin.

Poly(oxy-1,2-ethanediyl), .alpha.-dodecyl-.omega.-hydroxy-:
Result : Irritating to skin.

3(2H)-Isothiazolone, 2-methyl-, hydrochloride (1:1):


Result : Causes burns.

Serious eye damage/eye irritation


Causes serious eye damage.
Ingredients:

1-Tetradecanaminium, N,N,N-trimethyl-, bromide (1:1):


Result : Risk of serious damage to eyes.

Poly(oxy-1,2-ethanediyl), .alpha.-dodecyl-.omega.-hydroxy-:
Result : Risk of serious damage to eyes.

Respiratory or skin sensitization

Skin sensitization
May cause an allergic skin reaction.
Respiratory sensitization
May cause allergy or asthma symptoms or breathing difficulties if inhaled.
Ingredients:

3(2H)-Isothiazolone, 2-methyl-, hydrochloride (1:1):


Assessment : May cause sensitization by skin contact.

Assessment : May cause sensitization by inhalation.

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SAFETY DATA SHEET

C.f.a.s. HbA1c
Version Revision Date: Date of last issue: 06-15-2018
1.5 08-02-2018 Date of first issue: 11-20-2015

Germ cell mutagenicity


Not classified based on available information.
Ingredients:

Edetic acid disodium salt dihydrate (EDTA-2Na-2H2O):


Genotoxicity in vitro : Test Type: Ames test
Remarks: In vitro tests did not show mutagenic effects

Carcinogenicity
Not classified based on available information.
IARC No ingredient of this product present at levels greater than or equal to 0.1% is
identified as probable, possible or confirmed human carcinogen by IARC.

OSHA No component of this product present at levels greater than or equal to 0.1% is
on OSHA’s list of regulated carcinogens.

NTP No ingredient of this product present at levels greater than or equal to 0.1% is
identified as a known or anticipated carcinogen by NTP.

Reproductive toxicity
Not classified based on available information.
STOT-single exposure
Not classified based on available information.
Ingredients:

.alpha.-D-Glucopyranoside, .beta.-D-fructofuranosyl:
Assessment : The substance or mixture is not classified as specific target
organ toxicant, single exposure.

1-Tetradecanaminium, N,N,N-trimethyl-, bromide (1:1):


Routes of exposure : Inhalation
Target Organs : Respiratory system
Assessment : May cause respiratory irritation.

STOT-repeated exposure
May cause damage to organs through prolonged or repeated exposure if swallowed.
Ingredients:

.alpha.-D-Glucopyranoside, .beta.-D-fructofuranosyl:
Assessment : The substance or mixture is not classified as specific target
organ toxicant, repeated exposure.

Repeated dose toxicity

Ingredients:

1-Tetradecanaminium, N,N,N-trimethyl-, bromide (1:1):


Species : Rat
: 75 mg/kg

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SAFETY DATA SHEET

C.f.a.s. HbA1c
Version Revision Date: Date of last issue: 06-15-2018
1.5 08-02-2018 Date of first issue: 11-20-2015

Application Route : Oral


Test atmosphere : dust/mist
Exposure time : 21 d
Assessment : The substance or mixture is classified as specific target organ
toxicant, repeated exposure, category 2.

Aspiration toxicity
Not classified based on available information.
Ingredients:

.alpha.-D-Glucopyranoside, .beta.-D-fructofuranosyl:
No data available

Further information

Ingredients:

.alpha.-D-Glucopyranoside, .beta.-D-fructofuranosyl:
Remarks : Health injuries are not known or expected under normal use.

1-Tetradecanaminium, N,N,N-trimethyl-, bromide (1:1):


Remarks : Other dangerous properties can not be excluded.

SECTION 12. ECOLOGICAL INFORMATION

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Ecotoxicity

Ingredients:

.alpha.-D-Glucopyranoside, .beta.-D-fructofuranosyl:
Toxicity to fish : LC50: > 100 mg/l
Exposure time: 96 h

Ecotoxicology Assessment
Acute aquatic toxicity : This product has no known ecotoxicological effects.

Chronic aquatic toxicity : This product has no known ecotoxicological effects.

Toxicity Data on Soil : Not expected to adsorb on soil.

Other organisms relevant to : No data available


the environment

1-Tetradecanaminium, N,N,N-trimethyl-, bromide (1:1):


Toxicity to fish : LC50 (Danio rerio (zebra fish)): 1.81 mg/l
Exposure time: 96 h

Toxicity to daphnia and other : EC50 (Daphnia magna (Water flea)): 0.022 mg/l
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SAFETY DATA SHEET

C.f.a.s. HbA1c
Version Revision Date: Date of last issue: 06-15-2018
1.5 08-02-2018 Date of first issue: 11-20-2015

aquatic invertebrates Exposure time: 48 h

NOEC (Daphnia magna (Water flea)): 0.023 mg/l


Exposure time: 504 h

Toxicity to algae : EC50 (Pseudokirchneriella subcapitata (green algae)):


0.00538 mg/l
Exposure time: 72 h

NOEC (Pseudokirchneriella subcapitata (green algae)):


0.0013 mg/l
Exposure time: 72 h

Toxicity to microorganisms : EC50 (Natural microorganism): 19 mg/l

LC50 (Natural microorganism): 19 mg/l

Edetic acid disodium salt dihydrate (EDTA-2Na-2H2O):


Toxicity to fish : LC50 (Poecilia reticulata (guppy)): ca. 320 mg/l
Exposure time: 96 h
Test substance: anhydrous substance

LC50 (Leuciscus idus (Golden orfe)): > 500 mg/l


Exposure time: 96 h

Toxicity to daphnia and other : EC50 (Daphnia): > 100 mg/l


aquatic invertebrates Exposure time: 24 h

Toxicity to algae : ErC50 (Desmodesmus subspicatus (green algae)): > 100 mg/l
Exposure time: 72 h

Toxicity to microorganisms : EC50 (Pseudomonas putida): 56 mg/l


Exposure time: 8 h
Test substance: anhydrous substance

Ecotoxicology Assessment
Acute aquatic toxicity : This product has no known ecotoxicological effects.

Chronic aquatic toxicity : This product has no known ecotoxicological effects.

Toxicity Data on Soil : Not expected to adsorb on soil.

Other organisms relevant to : No data available


the environment

Poly(oxy-1,2-ethanediyl), .alpha.-dodecyl-.omega.-hydroxy-:
Toxicity to daphnia and other : EC50 (Daphnia magna (Water flea)): 6.46 mg/l
aquatic invertebrates Exposure time: 48 h

Ecotoxicology Assessment
Acute aquatic toxicity : Toxic to aquatic life.

Chronic aquatic toxicity : This product has no known ecotoxicological effects.


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SAFETY DATA SHEET

C.f.a.s. HbA1c
Version Revision Date: Date of last issue: 06-15-2018
1.5 08-02-2018 Date of first issue: 11-20-2015

Toxicity Data on Soil : Not expected to adsorb on soil.

Other organisms relevant to : No data available


the environment

3(2H)-Isothiazolone, 2-methyl-, hydrochloride (1:1):

Ecotoxicology Assessment
Acute aquatic toxicity : This product has no known ecotoxicological effects.

Chronic aquatic toxicity : This product has no known ecotoxicological effects.

Persistence and degradability

Ingredients:

1-Tetradecanaminium, N,N,N-trimethyl-, bromide (1:1):


Biodegradability : Result: Readily biodegradable.

Edetic acid disodium salt dihydrate (EDTA-2Na-2H2O):


Biodegradability : Biodegradation: 3 %
Testing period: 30 d
Method: Directive 67/548/EEC Annex V, C.4.C.
Remarks: According to the results of tests of biodegradability
this product is not readily biodegradable.

Biochemical Oxygen De- : 10 mg/g


mand (BOD) Incubation time: 5 d

Bioaccumulative potential

Ingredients:

.alpha.-D-Glucopyranoside, .beta.-D-fructofuranosyl:
Partition coefficient: n- : log Pow: -3.67
octanol/water

1-Tetradecanaminium, N,N,N-trimethyl-, bromide (1:1):


Bioaccumulation : Bioconcentration factor (BCF): 750
Remarks: Does not bioaccumulate.

Edetic acid disodium salt dihydrate (EDTA-2Na-2H2O):


Partition coefficient: n- : Remarks: No data available
octanol/water

Poly(oxy-1,2-ethanediyl), .alpha.-dodecyl-.omega.-hydroxy-:
Bioaccumulation : Species: Cyprinus carpio (Carp)
Bioconcentration factor (BCF): 220
Exposure time: 72 h

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SAFETY DATA SHEET

C.f.a.s. HbA1c
Version Revision Date: Date of last issue: 06-15-2018
1.5 08-02-2018 Date of first issue: 11-20-2015

Partition coefficient: n- : Remarks: No data available


octanol/water

3(2H)-Isothiazolone, 2-methyl-, hydrochloride (1:1):


Partition coefficient: n- : Remarks: Not applicable
octanol/water

Mobility in soil
No data available
Other adverse effects

Ingredients:

Poly(oxy-1,2-ethanediyl), .alpha.-dodecyl-.omega.-hydroxy-:
Additional ecological infor- : No data available
mation

SECTION 13. DISPOSAL CONSIDERATIONS

Disposal methods
Waste from residues : The product should not be allowed to enter drains, water
courses or the soil.
Do not contaminate ponds, waterways or ditches with chemi-
cal or used container.
Send to a licensed waste management company.

Contaminated packaging : Empty remaining contents.


Dispose of as unused product.
Empty containers should be taken to an approved waste
handling site for recycling or disposal.
Do not re-use empty containers.

SECTION 14. TRANSPORT INFORMATION

International Regulations

UNRTDG
Not regulated as a dangerous good
IATA-DGR
Not regulated as a dangerous good
IMDG-Code
Not regulated as a dangerous good
Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code
Not applicable
Domestic regulation

49 CFR
Not regulated as a dangerous good
13 / 18
SAFETY DATA SHEET

C.f.a.s. HbA1c
Version Revision Date: Date of last issue: 06-15-2018
1.5 08-02-2018 Date of first issue: 11-20-2015

SECTION 15. REGULATORY INFORMATION

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EPCRA - Emergency Planning and Community Right-to-Know

CERCLA Reportable Quantity


This material does not contain any components with a CERCLA RQ.
SARA 304 Extremely Hazardous Substances Reportable Quantity
This material does not contain any components with a section 304 EHS RQ.

SARA 302 Extremely Hazardous Substances Threshold Planning Quantity


This material does not contain any components with a section 302 EHS TPQ.
SARA 311/312 Hazards : Serious eye damage or eye irritation
Respiratory or skin sensitization
Specific target organ toxicity (single or repeated exposure)

SARA 313 : This material does not contain any chemical components with
known CAS numbers that exceed the threshold (De Minimis)
reporting levels established by SARA Title III, Section 313.

Clean Air Act


This product neither contains, nor was manufactured with a Class I or Class II ODS as defined by
the U.S. Clean Air Act Section 602 (40 CFR 82, Subpt. A, App.A + B).
This product does not contain any hazardous air pollutants (HAP), as defined by the U.S. Clean
Air Act Section 112 (40 CFR 61).
This product does not contain any chemicals listed under the U.S. Clean Air Act Section 112(r) for
Accidental Release Prevention (40 CFR 68.130, Subpart F).
This product does not contain any chemicals listed under the U.S. Clean Air Act Section 111
SOCMI Intermediate or Final VOC's (40 CFR 60.489).
Clean Water Act
This product does not contain any Hazardous Substances listed under the U.S. CleanWater Act,
Section 311, Table 116.4A.
The following Hazardous Chemicals are listed under the U.S. CleanWater Act, Section 311, Table
117.3:
Sodium phosphate diba- 10028-24-7 >= 1 - < 5 %
sic dihydrate
This product does not contain any toxic pollutants listed under the U.S. Clean Water Act Section
307
US State Regulations

Massachusetts Right To Know


.alpha.-D-Glucopyranoside, .beta.-D-fructofuranosyl 57-50-1
Sodium phosphate dibasic dihydrate 10028-24-7
Pennsylvania Right To Know
.alpha.-D-Glucopyranoside, .beta.-D-fructofuranosyl 57-50-1
Albumins, blood serum 9048-46-8
1-Tetradecanaminium, N,N,N-trimethyl-, bromide (1:1) 1119-97-7
Edetic acid disodium salt dihydrate (EDTA-2Na-2H2O) 6381-92-6
Animal serum /-plasma /- hemolysate - different species, ly- Not Assigned
ophilized
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SAFETY DATA SHEET

C.f.a.s. HbA1c
Version Revision Date: Date of last issue: 06-15-2018
1.5 08-02-2018 Date of first issue: 11-20-2015

Sodium phosphate dibasic dihydrate 10028-24-7


Maine Chemicals of High Concern
Product does not contain any listed chemicals
Vermont Chemicals of High Concern
Product does not contain any listed chemicals
Washington Chemicals of High Concern
Product does not contain any listed chemicals
California Prop. 65
This product does not contain any chemicals known to the State of California to cause cancer,
birth, or any other reproductive defects.
California Permissible Exposure Limits for Chemical Contaminants
.alpha.-D-Glucopyranoside, .beta.-D-fructofuranosyl 57-50-1
The ingredients of this product are reported in the following inventories:
DSL : This product contains the following components that are not
on the Canadian DSL nor NDSL.

Animal serum /-plasma /- hemolysate - different species,


lyophilized

AICS : Not in compliance with the inventory

NZIoC : On the inventory, or in compliance with the inventory

ENCS : Not in compliance with the inventory

ISHL : Not in compliance with the inventory

KECI : Not in compliance with the inventory

PICCS : Not in compliance with the inventory

IECSC : Not in compliance with the inventory

TCSI : Not in compliance with the inventory

TSCA : Not On TSCA Inventory

TSCA list
No substances are subject to a Significant New Use Rule.

No substances are subject to TSCA 12(b) export notification requirements.

R1

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SAFETY DATA SHEET

C.f.a.s. HbA1c
Version Revision Date: Date of last issue: 06-15-2018
1.5 08-02-2018 Date of first issue: 11-20-2015

GHS label elements


Hazard pictograms :

Signal Word : Danger

Hazard Statements : H317 May cause an allergic skin reaction.


H318 Causes serious eye damage.
H334 May cause allergy or asthma symptoms or breathing
difficulties if inhaled.
H373 May cause damage to organs through prolonged or re-
peated exposure if swallowed.

Precautionary Statements :
Prevention:
P260 Do not breathe dust/ fume/ gas/ mist/ vapors/ spray.
P272 Contaminated work clothing must not be allowed out of
the workplace.
P280 Wear protective gloves/ eye protection/ face protection.
P285 In case of inadequate ventilation wear respiratory protec-
tion.
Response:
P302 + P352 IF ON SKIN: Wash with plenty of soap and water.
P304 + P341 IF INHALED: If breathing is difficult, remove per-
son to fresh air and keep comfortable for breathing.
P305 + P351 + P338 + P310 IF IN EYES: Rinse cautiously with
water for several minutes. Remove contact lenses, if present
and easy to do. Continue rinsing. Immediately call a POISON
CENTER/doctor.
P333 + P313 If skin irritation or rash occurs: Get medical ad-
vice/ attention.
P342 + P311 If experiencing respiratory symptoms: Call a
POISON CENTER/doctor.
P363 Wash contaminated clothing before reuse.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.

SECTION 16. OTHER INFORMATION

Further information

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SAFETY DATA SHEET

C.f.a.s. HbA1c
Version Revision Date: Date of last issue: 06-15-2018
1.5 08-02-2018 Date of first issue: 11-20-2015

R1
NFPA: HMIS® IV:
Flammability
HEALTH * 3
0
FLAMMABILITY

Instability
0
Health

3 0
PHYSICAL HAZARD
0

HMIS® ratings are based on a 0-4 rating


scale, with 0 representing minimal haz-
ards or risks, and 4 representing signifi-
Special hazard.
cant hazards or risks. The "*" represents
a chronic hazard, while the "/" represents
the absence of a chronic hazard.

Full text of other abbreviations

AICS - Australian Inventory of Chemical Substances; ASTM - American Society for the Testing of
Materials; bw - Body weight; CERCLA - Comprehensive Environmental Response, Compensation,
and Liability Act; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the
German Institute for Standardisation; DOT - Department of Transportation; DSL - Domestic Sub-
stances List (Canada); ECx - Concentration associated with x% response; EHS - Extremely Haz-
ardous Substance; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized Sys-
tem; GLP - Good Laboratory Practice; HMIS - Hazardous Materials Identification System; IARC -
International Agency for Research on Cancer; IATA - International Air Transport Association; IBC
- International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals
in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organiza-
tion; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime
Dangerous Goods; IMO - International Maritime Organization; ISHL - Industrial Safety and Health
Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemi-
cals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to
50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Pre-
vention of Pollution from Ships; MSHA - Mine Safety and Health Administration; n.o.s. - Not Oth-
erwise Specified; NFPA - National Fire Protection Association; NO(A)EC - No Observed (Adverse)
Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable
Effect Loading Rate; NTP - National Toxicology Program; NZIoC - New Zealand Inventory of
Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office
of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic sub-
stance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quanti-
tative) Structure Activity Relationship; RCRA - Resource Conservation and Recovery Act;
REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concern-
ing the Registration, Evaluation, Authorisation and Restriction of Chemicals; RQ - Reportable
Quantity; SADT - Self-Accelerating Decomposition Temperature; SARA - Superfund Amend-
ments and Reauthorization Act; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance
Inventory; TSCA - Toxic Substances Control Act (United States); UN - United Nations; UNRTDG -
United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent
and Very Bioaccumulative

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SAFETY DATA SHEET

C.f.a.s. HbA1c
Version Revision Date: Date of last issue: 06-15-2018
1.5 08-02-2018 Date of first issue: 11-20-2015

Revision Date : 08-02-2018

The information provided in this Material Safety Data Sheet is correct to the best of our
knowledge, information and belief at the date of its publication. The information given is designed
only as a guidance for safe handling, use, processing, storage, transportation, disposal and re-
lease and is not to be considered a warranty or quality specification. The information relates only
to the specific material designated and may not be valid for such material used in combination
with any other materials or in any process, unless specified in the text.

US / Z8 / 1711

18 / 18

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